7Annual charges for biologics and some other goods

7 Annual charges for biologics and some other goods

Registration or listing of non‑grouped therapeutic goods (1) For the purposes of subsection 4(1) of the Act, the annual charges for the registration or listing of therapeutic goods (other than grouped therapeutic goods) are: (a) for goods whose registration is in force at any time during the charge year and that are of a kind not mentioned in Part 1 of Schedule 10 to the Therapeutic Goods Regulations 1990: (i) if the goods are a medicine—$1,939; and (iii) in any other case—$2,149; and (b) for goods: (i) whose registration is in force at any time during the charge year; and (ii) that are of a kind mentioned in Part 1 of Schedule 10 to the Therapeutic Goods Regulations 1990; and (iii) that are a biologic; $9,428; and (c) for goods (other than goods produced for export) the listing of which is in force at any time during the charge year: (i) if the goods are a medicine—$1,473; and (iii) in any other case—$1,111.

Note: For goods of a kind mentioned in Part 1 of Schedule 10 to the Therapeutic Goods Regulations 1990 that are not a biologic, see section 8.

Registration or listing of grouped therapeutic goods (2) For the purposes of subsection 4(1A) of the Act, the annual charge for the registration or listing of grouped therapeutic goods is: (a) for grouped goods whose registration is in force at any time during the charge year and that are of a kind not mentioned in Part 1 of Schedule 10 to the Therapeutic Goods Regulations 1990: (i) if the goods are medicines—$1,939; and (iii) in any other case—$2,149; and (b) for grouped therapeutic goods: (i) whose registration is in force at any time during the charge year; and (ii) that are of a kind mentioned in Part 1 of Schedule 10 to the Therapeutic Goods Regulations 1990; and (iii) that are biologics; $9,428; and (c) for grouped goods (other than goods all of which are produced for export) the listing of which is in force at any time during the charge year: (i) if the goods are medicines—$1,473; and (iii) in any other case—$1,111.

Note: For grouped therapeutic goods of a kind mentioned in Part 1 of Schedule 10 to the Therapeutic Goods Regulations 1990 that are not biologics, see section 8.

Biologicals (3) For the purposes of subsection 4(1AA) of the Act, the annual charges for inclusion of a biological (other than an export only biological) in the Register under Part 3‑2A of the Therapeutic Goods Act 1989 are: (a) for a Class 1 biological whose inclusion in the Register is in force at any time during the charge year—$881; and (b) for a Class 2, Class 3 or Class 4 biological whose inclusion in the Register is in force at any time during the charge year—$8,760. Medical devices (4) For the purposes of subsection 4(1B) of the Act, the annual charges in respect of the inclusion of kinds of medical devices (other than medical devices produced for export) in the Register under Chapter 4 of the Therapeutic Goods Act 1989 that has effect at any time during the charge year are as follows: (a) for a Class I medical device (other than a Class I medical device to which paragraph (b) applies)—$114; (b) for a Class I medical device that the manufacturer intends to be supplied in a sterile state or that has a measuring function—$828; (c) for a Class IIa medical device or Class IIb medical device—$1,230; (d) for a Class III medical device—$1,566; (e) for an IVD medical device (of a class other than a Class 4 in‑house IVD medical device)—$893; (f) for a Class 4 in‑house IVD medical device—nil. Licences (5) For the purposes of subsection 4(2) of the Act, the annual charge for a licence that is in force at any time during the charge year is as follows: (a) for a licence for one or more steps in the manufacture of sterile or non‑sterile therapeutic goods—$6,020; (b) for a licence for the manufacture of containers in which therapeutic goods are to be packed—$6,020; (c) for a licence for the manufacture of ingredients or components for use in the manufacture of therapeutic goods—$6,020; (e) for a licence for the manufacture of herbal or homoeopathic preparations that are not included in a Schedule to the current Poisons Standard (other than Schedule 5 or 6)—$6,020; (f) for a licence for the manufacture of human blood and blood components (other than haematopoietic progenitor cells) at manufacturing premises covered by the licence: (i) for the principal premises in the capital city of a State or Territory where human blood and blood components are manufactured—$210,610; and (ii) for a fixed (non‑mobile) manufacturing site—$10,368; (g) for a licence for the manufacture of haematopoietic progenitor cells at manufacturing premises covered by the licence—$9,070; (h) for a licence for a single step in the manufacture of a single human tissue at manufacturing premises covered by the licence—$9,070; (i) for a licence for 2 or more steps in the manufacture of human tissues at manufacturing premises covered by the licence—$17,738; (j) despite paragraphs (a) to (i)—for a licence for the manufacture of a biological only—nil. Only highest applicable charge is payable (6) If, but for this subsection, more than one charge referred to in subsection (1) or any of paragraphs (5)(a) to (i) would otherwise apply in respect of a charge year in relation to: (a) the registration or listing of particular goods; or (b) a particular licence; only the highest applicable charge (other than a charge payable under any of paragraphs (5)(a) to (i) only because biologicals are manufactured) applies in respect of the registration or listing of those goods or in relation to that licence in that year.